Teragezza 2000/35microgram film-coated tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: myHealthbox

सक्रिय संघटक:

cyproterone acetate, ethinylestradiol

थमां उपलब्ध:

Morningside Healthcare Ltd

ए.टी.सी कोड:

G03HB01

INN (इंटरनेशनल नाम):

cyproterone acetate, ethinylestradiol

डोज़:

2000/35microgram

फार्मास्यूटिकल फॉर्म:

Film-coated tablets

प्रशासन का मार्ग:

Oral use

पैकेज में यूनिट:

Packs of 21, 63 and 126 Tablets

प्रिस्क्रिप्शन प्रकार:

POM - Prescription Only Medicine

द्वारा बनाया गया:

Morningside Pharmaceutical Ltd

चिकित्सीय समूह:

cyproterone and estrogen

चिकित्सीय संकेत:

Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, co-cyprindiol should only be used after topical therapy or systemic antibiotic treatments have failed.

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2015-03-03

सूचना पत्रक

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DOCUMENT OUTLINE * Page 1

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Teragezza 2000/35 microgram film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains: 

Actives: 
Cyproterone acetate  2.00 mg 
Ethinylestradiol 35 
micrograms 

Excipients:  
Lactose monohydrate  57.44mg 

For full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Film-coated tablets. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Treatment of moderate to severe acne
related to androgen-sensitivity (with or without 
seborrhoea) and/or hirsutism, in women of reproductive age. 

For the treatment of acne, co-cyprindiol should only be used
after topical therapy or 
systemic antibiotic treatments have failed. 

Since co-cyprindiol is also a hormonal contraceptive, it should
not be used in 
combination with other hormonal contraceptives (see section 4.3).  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Co-cyprindiol inhibits ovulation and thereby prevents conception.
Patients who are 
using co-cyprindiol should not therefore use an additional
hormonal contraceptive, as 
this will expose the patient to an excessive dose of hormones and
is not necessary for 
effective contraception.  

_First treatment course:_  One tablet daily for 21 days,
starting on the first day of the 
menstrual cycle (the first day of menstruation counting as
Day 1). 

_Subsequent courses:_  Each subsequent course is started
after 7 tablet-free days have 
followed the preceding course. 

When the contraceptive action of co-cyprindiol is also to
be employed, it is essential 
that the above instructions be rigidly adhered to.  Should
bleeding fail to occur during 
the tablet-free interval, the possibility of pregnancy must
be excluded before the next 
pack is started. 

When changing from an oral contraceptive and relying on
the con